Safety evaluation of a food enzyme containing trypsin and chymotrypsin from porcine pancreas.
Résumé
The food enzyme is a serine protease complex containing trypsin (EC 3.4.21.4) and chymotrypsin (EC3.4.21.1) obtained from porcine pancreas by Paninkret Chem.-Pharm. Werk GmbH. The food enzyme iscurrently only used in protein processing to hydrolyse milk proteins. Milk protein hydrolysates andpeptides are mainly used in formulae intended to have reduced allergenicity. Based on the recommendeduse level and the high consumption of formulae in very young babies, dietary exposure to the foodenzyme–total organic solids (TOS) was estimated to be 180 mg TOS/kg body weight (bw) per day forinfants and toddlers. Toxicological evaluation was based on the available clinical studies with pancreaticenzymes. Hypersensitivity to the product was identified as the major side effect. However, the intactenzymes are inactivated during preparation of food products; therefore, the Panel considered that thelikelihood of adverse effects of the intact enzyme to occur is low. The Panel considered that a risk ofallergic sensitisation to these protein hydrolysates after consumption cannot be excluded, but thelikelihood of occurrence was considered to be low. Based on the origin of the food enzyme from edibleparts of animals, the data provided and the evaluation of clinical studies with pancreatic enzymes and theestimated dietary exposure, the Panel concluded that the food enzyme does not give rise to safetyconcerns when used in the production of infant formulae based on milk protein hydrolysates.
Domaines
Sciences du Vivant [q-bio]
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EFSA Journal - 2021 - - Safety evaluation of a food enzyme containing trypsin and chymotrypsin from porcine pancreas.pdf (1.29 Mo)
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